-- Completion of IND submission for NDI-219216, a non-covalent WRN inhibitor for treatment of MSI-H tumors, with plans to initiate clinical trial in 1H 2025 --

-- Appointment of Peter J. Tummino as President of R&D --

-- Company to present pipeline update at 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025 at 7:30 a.m. PT --

BOSTON: Nimbus Therapeutics, LLC ("Nimbus Therapeutics" or "Nimbus"), a biotechnology company that designs and develops breakthrough medicines for patients through its powerful computational drug discovery engine, today announced the advancement of its clinical oncology therapeutic pipeline, and the appointment of Peter J. Tummino, Ph.D., to President of Research and Development. Dr. Tummino will be responsible for advancing the company’s product portfolio through all phases of discovery and clinical development.

The company announced the completion of an investigational new drug (IND) application submission for NDI-219216, a novel Werner syndrome helicase (WRN) inhibitor in development for the treatment of microsatellite instability high (MSI-H) tumors. Nimbus plans to initiate the first clinical trial of NDI-219216 in the first half of 2025 under the leadership of Anita Scheuber, M.D., Ph.D., Senior Vice President, Therapeutic Area Head, Oncology.

"We are encouraged by the building momentum in our oncology portfolio including important advances in our non-covalent WRN inhibitor program, with data indicating NDI-219216 has the potential to be a best-in-class agent," said Dr. Tummino.

"NDI-219216 has demonstrated compelling preclinical data, including significant tumor regression and complete responses at low oral doses across tumor types. The preclinical safety studies suggest a promising benefit-risk profile as we prepare to evaluate this compound in patients. We are excited to advance NDI-219216 into a first-in-human clinical trial later this year," said Dr. Scheuber.

The company recently completed its Phase 1/2 clinical study of NDI-101150, a highly selective and potent hematopoietic progenitor kinase 1 (HPK1) inhibitor, for the treatment of advanced solid tumors. Clinical data presented in November 2024 at the Society for Immunotherapy of Cancer (SITC) 39th Annual Meeting demonstrated monotherapy efficacy with a favorable safety profile that supports potential combination therapy approaches. The company is actively evaluating opportunities to maximize the therapeutic potential of this program.

Nimbus continues to progress drug discovery efforts across metabolic and autoimmune targets as well, including the development of novel therapies that activate AMP-activated protein kinase (AMPK) to treat metabolic disorders as part of an ongoing research collaboration and exclusive worldwide license agreement with Eli Lilly and Company. Nimbus has also expanded its pipeline with the addition of new undisclosed therapeutic targets leveraging its novel computational and structure-based drug design approach.

"Nimbus made significant progress in 2024 in our discovery and development programs across oncology, immunology, and metabolism, bringing us one step closer to our ultimate goal of delivering transformative medicines to patients," said Jeb Keiper, M.S., M.B.A., Chief Executive Officer of Nimbus. "Peter’s appointment to President of R&D reflects his exceptional leadership and deep expertise in drug discovery and development, and his expanded role will be instrumental in advancing our innovative pipeline. We continue to broaden our drug discovery engine to unlock new difficult-to-drug targets with compelling biology through deep computational expertise, a breadth of internal drug discovery expertise, and key partnerships. We look forward to multiple key milestones in the coming year."

Mr. Keiper will provide an overview of the company’s progress, pipeline, and anticipated milestones for 2025 and beyond at the 43rd Annual J.P. Morgan Healthcare Conference on Monday, January 13, 2025 at 7:30 a.m. PT.

About Nimbus Therapeutics

Nimbus Therapeutics is a clinical-stage, structure-based drug discovery company developing novel small molecule medicines designed to act against well-validated but difficult-to-drug targets implicated in multiple human diseases. The company advances promising research based on a unique strategy that combines leading-edge computational technologies with a tailored array of machine learning-based predictive modeling approaches. Nimbus' pipeline includes NDI-219216, a Werner syndrome helicase (WRN) inhibitor in development for microsatellite instability high (MSI-H) tumors, as well as a diverse portfolio of preclinical programs focused on cancer, autoimmune conditions, and metabolic diseases. The company is headquartered in Boston, Mass. To learn more about Nimbus, please visit www.nimbustx.com.

Fonte: Business Wire